United States securities and exchange commission logo
July 12, 2023
Jason Hanson
Chief Executive Officer
enGene Holdings Inc.
7171 Rue Frederick Banting
Saint-Laurent, QC H4S IZ9, Canada
Re: enGene Holdings
Inc.
Draft Registration
Statement on Form S-4
Submitted June 14,
2023
CIK No. 0001980845
Dear Jason Hanson:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Draft Registration Statement on Form S-4
Cover Page
1. Please revise your
cover page to disclose the valuation assigned to enGene for purposes of
the Business
Combination.
Questions and Answers About the Business Combination and the Special
Meeting
Q: Why is FEAC proposing the Business Combination, page 11
2. You state that in
approving the business combination the FEAC board considered certain
factors and proceed to
discuss them. Please revise your answer to balance the description
with equally prominent
disclosure of regulatory and competitive challenges you face.
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
July NameenGene Holdings Inc.
12, 2023
July 12,
Page 2 2023 Page 2
FirstName LastName
3. In the second bullet point on page 12, please specify the milestones
that the FEAC Board
considered that could provide an opportunity for potential uplifts in
enGene s valuation.
Q: What interests do FEAC's current officers and directors have in the Business
Combination?,
page 14
4. Please quantify any out-of-pocket expenses for which the sponsor and
its affiliates are
awaiting reimbursement.
Q: What equity stake will current FEAC Shareholders, the enGene Shareholders
and the
Sponsor..., page 19
5. Please add a table showing the pro forma ownership interests described
in this section, as
expanded to include each group of security holders, based on all
shares that may be issued
on a fully-diluted basis, including the ownership interests of the
PIPE investors and the
Convertible Bridge Financing investors, based on a no redemption
scenario, a 50%
redemption scenario and a maximum redemption scenario, including any
needed
assumptions. Ensure your revised disclosure addresses all possible
sources and extent of
dilution that shareholders who elect not to redeem their shares may
experience in
connection with the business combination. Provide disclosure of the
impact of each
significant source of dilution, including the amount of equity held by
founders,
convertible securities, including warrants retained by redeeming
shareholders, at each of
the redemption levels detailed in your sensitivity analysis, including
any needed
assumptions.
6. Quantify the value of warrants, based on recent trading prices, that
may be retained by
redeeming shareholders assuming maximum redemptions and identify any
material
resulting risks.
7. It appears that underwriting fees remain constant and are not adjusted
based on
redemptions. Revise to disclose the effective underwriting fee on a
percentage basis for
shares at each redemption level presented in your sensitivity analysis
related to dilution.
Q: What is the PIPE Financing?, page 24
8. Please highlight in this question and answer, and in the next question
and answer
regarding the Convertible Bridge Financing, the material differences
in the price of the
FEAC Shares issued at the time of the IPO and the price of the
securities being issued in
the private placements at the time of the Business Combination.
Disclose if the SPAC s
sponsors, directors, officers or their affiliates will participate in
the private placements.
The Non-Redemption Agreement, page 34
9. Please disclose the number of FEAC Class A Shares and FEAC Warrants
(or after the
Assumption, the number of New enGene Shares and New enGene Warrants)
issuable to
the FEAC Shareholders under the Non-Redemption Agreement.
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
July NameenGene Holdings Inc.
12, 2023
July 12,
Page 3 2023 Page 3
FirstName LastName
Conditions to Closing, page 36
10. We note your disclosure that it is a condition to closing that New
enGene s initial listing
application with the Nasdaq or other exchange shall have been approved
but such
condition appears to be waivable. Please revise to disclose whether
the terms of the
Business Combination Agreement permit that the Nasdaq listing closing
condition could
be waived without recirculation or resolicitation. If so, please
revise the risk factor on
page 145 to reflect as such and describe the risks attendant to such a
waiver, and revise
this section to indicate that shareholders may not have certainty at
the time they vote or
make their redemption decision as to whether the New enGene s
securities will be listed
on a national securities exchange following the business combination.
Interests of enGene's Significant Shareholders, Directors and Executive
Officers in the Business
Combination, page 43
11. Please expand your disclosure regarding Forbion Capital Fund III's
ownership interests in
enGene. Disclose the approximate dollar value of the interests based
on the transaction
value and recent trading prices as compared to the price paid for the
ownership interests.
In addition, please clarify how the FEAC Board considered these
interests in negotiating
and recommending the Business Combination.
Potential Purchases of Shares and/or Public Warrants, page 159
12. We note your disclosure here and on page 137 that the Sponsor, enGene
and/or its
affiliates may purchase shares and/or warrants in privately negotiated
transactions or in
the open market from public shareholders, or they may enter into
transactions with
investors and others to provide them with incentives to acquire shares
of FEAC Class A
Shares or vote their shares in favor of the Business Combination, and
that the purpose of
such purchases and other transactions could be to vote such shares in
favor of the Business
Combination and thereby increase the likelihood of obtaining
shareholder approval. In an
appropriate location, please disclose how such purchases will comply
with the
requirements of Rule 14e-5 under the Exchange Act. Refer to Tender
Offer Rules and
Schedules Compliance and Disclosure Interpretation 166.01 for
guidance.
Proposal No. 1 - The Business Combination Proposal
Background of the Business Combination, page 164
13. We note that in identifying enGene, FEAC's management identified 85
potential targets,
entered into 31 non-disclosure agreements, and submitted three letters
of intent. Please
expand this section to discuss how such companies were identified and
what criteria was
used to not consider certain companies.
14. We note you entered into three letters of intent, one being with
enGene. Please provide a
general description of the other two targets and disclose when you
ended discussions with
those companies.
Jason Hanson
enGene Holdings Inc.
July 12, 2023
Page 4
15. You state that on May 13, 2022 representatives of FEAC and
representatives of enGene
met to discuss valuation and the potential size of a PIPE financing.
You also state that
further meetings were held on May 22, 2022 and May 30, 2022. Please
identify the
representatives of enGene that were present and include a description
of the discussions
that took place on May 22, 2022 and May 30, 2022.
16. You state that on May 31, 2022 the FEAC Board convened to approve a
draft non-binding
letter of interest. Please include a discussion of the key terms that
were approved.
17. We note that on August 29, 2022 Morgan Lewis granted virtual data room
access to
Kirkland & Elis and Davis Polk & Wardwell London LLP. Please identify
who Davis
Polk is representing in this transaction.
18. You state that on September 29, 2022 and October 31, 2022 a Big Four
accounting firm
was appointed advisor to FEAC. Please identify the accounting firm.
19. We note your disclosure that on March 23, 2023, Davis Polk had a
telephonic meeting
with Morgan Lewis to discuss the presentation of certain of enGene s
phase 2 study data
to potential PIPE investors. Please tell us where you have disclosed
that data in your
proxy statement/prospectus or revise your disclosure as appropriate.
20. We note your disclosure on page 175 that on May 14, 2023, the FEAC
Board
unanimously approved the entry into the Business Combination Agreement
and Ancillary
Agreements and the transactions contemplated thereby. Please disclose
what the pre-
money valuation of enGene was for purposes of the Business Combination
Agreement
that the FEAC Board approved. If that valuation changed from the $200
million pre-
money valuation for purposes of the May 5, 2022 initial non-binding
business
combination proposal as disclosed on page 166, and the $200 million
pre-money valuation
for purposes of the signed letter of intent on July 3, 2022 as
disclosed on page 167, please
revise to provide a discussion as to how the material terms of the
consideration evolved
during the negotiations. In your revised disclosure, please ensure
that investors can tie the
valuation negotiations in the background section to the disclosure on
page 186 that, for
purposes of the fairness opinion, Lincoln derived an implied
enterprise value of enGene
from the Transaction of $111 million.
21. We note that FEAC's amended and restated memorandum and articles of
association
waived the corporate opportunities doctrine. Please address this
potential conflict of
interest and whether it impacted FEAC's search for an acquisition
target.
The FEAC Board's Reasons for the Business Combination, page 176
22. We note that none of your factors in deciding to approve the proposed
business
FirstName LastNameJason Hanson
combination address the consideration to be paid for enGene in the
transaction. Please
Comapany NameenGene
discuss whether and Holdings
how theInc.
board took this factor into account in
recommending the
transaction and,
July 12, 2023 Page 4 if not, why not.
FirstName LastName
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
July NameenGene Holdings Inc.
12, 2023
July 12,
Page 5 2023 Page 5
FirstName LastName
Lincoln's Fairness Opinion, page 182
23. Please supplementally provide us with copies of all materials prepared
by Lincoln
International LLC and shared with the FEAC board of directors and
their representatives,
including any board books, transcripts and summaries of oral
presentations, that were
material to the board's decision to approve the merger and the
transactions contemplated
thereby.
Survival of Representations, Warranties and Covenants, page 207
24. We note your disclosure that the representations and warranties of the
parties contained in
the Business Combination Agreement do not survive the Closing and that
there are no
indemnification rights. Please include appropriate risk factor
disclosure.
Unaudited Pro forma Condensed Combined Financial Information
Unaudited Pro Forma Condensed Combined Balance Sheet, page 241
25. You state in Note 5b on page 250 that the $18.5 million 2022
Convertible Notes and $38.0
million 2023 convertible notes will convert into 33,127,334 enGene
common shares.
Please clarify how the 33,127,334 shares were derived.
26. Please revise the explanation of adjustment 5(i) on page 251 to
explain how the
121,342,000 was derived.
27. You state in adjustment 5u on page 252 that the PIPE warrants are
preliminarily expected
to be equity-classified warrants as they meet the indexation
requirements under ASC 815-
40. Please clarify the basis of your accounting treatment for the
warrants to be issued in
connection with the PIPE financing once the terms have been finalized.
Provide the
applicable paragraphs in the agreement that support your conclusion.
28. You disclose on page F-61 a forward purchase agreement in which the
Sponsor has agreed
to purchase (1) an aggregate of 1,000,000 Class A ordinary shares for
$10.00 per share
(the "firm forward purchase shares"), or an aggregate amount of
$10,000,000 and (2) in
addition, an aggregate of up to 1,000,000 Class A ordinary shares for
$10.00 per share
(the "additional forward purchase shares"), or an aggregate maximum
amount of up to
$10,000,000, in each case in a private placement that may close
simultaneously with the
closing of the Company s initial Business Combination. Please
provide us your
consideration of including the issuance in the pro forma information
and providing
additional disclosure in the filing of the status of the agreement.
Business of enGene
Overview, page 279
29. You state that EG-70 is being developed to treat "high grade"
non-muscle invasive
bladder cancer (NMIBC) that has elements of carcinoma in situ "Cis."
Please define "high
grade" and "carcinoma in situ" and describe such elements. We also
note in this regard
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
July NameenGene Holdings Inc.
12, 2023
July 12,
Page 6 2023 Page 6
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that you disclose here that EG-70 is being developed to treat "high
grade non-
muscle invasive bladder cancer ("NMIBC") that has elements of
carcinoma in situ
("Cis")" but that in other locations you disclose that EG-70 is being
developed as a
monotherapy for BCG-unresponsive NMIBC with Cis. Please indicate if
the potential
market for this candidate would be limited to patient populations with
"high grade"
NMIBC with Cis and, if appropriate, revise your disclosure for
consistency.
30. Please disclose the addressable market or patient populations for
enGene's product
candidates in the countries and jurisdictions where EnGene currently
intends to seek
regulatory approval. For EG-70, please include the projections
referred to on page 84 for
the number of people who have the disease that the product candidate
is targeting, as well
as the subset of people with the disease in a position to receive
enGene's therapies, if
approved.
31. We note your disclosure that EG-70 has been given "Fast Track"
designation by the FDA.
Please revise to include balancing disclosure that an accelerated
approval pathway may
not lead to a faster development or regulatory review or approval
process and does not
increase the likelihood that your product candidate will receive
marketing approval.
Focus on advancing our lead product candidate EG-70. . . , page 280
32. You state here and on page 286 that you have followed the FDA guidance
for NMIBC
treatment and have discussed your EG-70 development plan with the FDA.
Please state
the status of such discussions and any feedback received from the FDA.
Fast Tracked Product Candidate in Underserved Market, page 281
33. You state that across all dose levels tested in the Phase I study of
EG-70, a 3-month
complete response rate of 71% (N=21) was observed and that Phase 1
patients who were
treated in the RP2D cohort and who elected to continue treatment and
receive an
additional 12-week cycle had a 57% CR rate at 6-months (4 out of 7).
Please expand the
discussion to explain the statistical significance of these
observations.
Our Gene Therapy Platform for Mucosal Tissues, page 281
34. At first use, please define viral vectors, AAV viral vectors, TURBT,
and cystoscopic
CR in layman terms.
Product and Pipeline Development, page 282
35. We note your pipeline table on page 283 showing the current status of
your product
development. Please revise the table to include columns for Phase 1, 2
and 3 clinical
trials.
Unmet Medical Need, page 285
36. You state that the FDA recently approved Adstilandrin for patients
with BCG-
Jason Hanson
enGene Holdings Inc.
July 12, 2023
Page 7
unresponsive high risk NMIBC. Please include a brief description of
the results found in
patients who received the treatment.
Legend: A Phase 1/2 Study of EG-70 in NMIBC, page 287
37. You make some assertions regarding the safety and/or efficacy of
mEG-70 and EG-70.
Please revise your disclosure to eliminate suggestions of safety and
efficacy as those
determinations are solely within the authority of the FDA or
comparable foreign
regulators. You may present clinical trial end points and objective
data without
concluding efficacy and you may state that your product is well
tolerated, if accurate.
Please revise or remove statements/inferences throughout your
prospectus that your
product candidate is safe and/or effective. For instance, and without
limitation, we note
the following statements about your drug candidates:
with the efficacy data, proof-of-mechanism that local urothelial
transfection with EG-
70 is efficacious for NMIBC (pg. 289);
We believe these data demonstrate the rapid, robust, and durable
efficacy of mEG-
70 in the orthotopic model of bladder cancer (pg. 294);
Given that mEG-70 mediated the induction of IL-12 and RIG-I
signaling, which was
coupled to robust efficacy... (pg. 295);
We believe these data demonstrate that mEG-70 effectively
remodeled the bladder
TME to promote tumor cell killing (pg. 295);
EG-70 has demonstrated a favorable safety profile when instilled
intravesically (pg.
298); and
[w]e have also demonstrated efficacy in models of ovarian cancer
and
glioblastoma (pg. 299).
Study Design, page 287
38. We note your disclosure of the clinical trials for EG-70. Please
expand your description
to include the dates of the trial and the regulatory jurisdictions
where the trials were
conducted. In addition, please revise to clarify whether the Phase I
trial was powered for
statistical significance. If the Phase I trial was powered for
statistical significance, please
provide the p-values for the results of the trial.
39. You state on page 318 that you are currently in Phase 1a clinical
trial for EG-70 and will
advance to Phase 1b clinical trials. Please include a discussion here
of which parts of the
Phase 1 clinical trial is considered part a and part b.
Results: Efficacy, page 288
40. We note your chart regarding efficacy assessment. Please revise this
chart so that all of
FirstName LastNameJason Hanson
your text is legible. We note the text appearing directly below the
table is too small to be
Comapany NameenGene
legible. Holdings
Further, please also Inc.
revise the charts on page 294 and 297 so
that all of the text is
July 12,legible.
2023 Page 7
FirstName LastName
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
July NameenGene Holdings Inc.
12, 2023
July 12,
Page 8 2023 Page 8
FirstName LastName
Gynecological, Genitourinary, page 299
41. We note your chart on page 299 regarding additional organs where you
have delivered
EG-70 via multiple routes of administration. Please revise the
"efficacy" column as
efficacy determinations are solely within the authority of the FDA or
applicable foreign
regulators. Further, please include descriptions of the route of
administration, proof of
concept, and pharmacokinetics/pharmacodynamics for each organ to the
extent material.
enGene's Management's Discussion and Analysis of Financial Condition and
Results of
Operations
Funding Requirements, page 329
42. We note your disclosure that giving pro forma effect to the Business
Combination,
including the PIPE Financing and other transactions and assumptions
set forth in the
"Unaudited Pro Forma Condensed Combined Financial Information" and
further assuming
the maximum redemption scenario, as of October 31, 2022, pro forma
cash and cash
equivalents would have been $113.3 million. Please disclose how far in
the development
process you currently expect to reach for EG-70 and EG-i08 with that
amount of cash and
cash equivalents.
Security Ownership of Certain Beneficial Owners and Management of enGene, page
368
43. Please identify in the footnotes to the table all natural persons who
directly or indirectly
exercise sole or shared voting and/or dispositive power with respect
to the securities held
by Epic Ventures Inc. and Fonds de solidarit des travailleurs du Qu
bec.
Material U.S. Federal Income Tax Considerations, page 383
44. We note your disclosure that FEAC intends to treat the FEAC
Reorganization as a
reorganization described in Section 368(a)(1)(F) of the Code.
Please revise your disclosure to provide counsel's firm opinion
for each material tax
consequence described in this section, including but not limited
to whether the
Business Combination will qualify as a reorganization under
Section 368(a)(1)(F) of
the Code, or to disclose why such opinion cannot be given. If the
opinion is subject
to uncertainty, please provide an opinion that reflects the degree
of uncertainty (e.g.,
"should" or "more likely than not") and explains the facts or
circumstances giving
rise to the uncertainty. Please refer to Item 601(b)(8) of
Regulation S-K and Section
III.A. of Staff Legal Bulletin 19, Legality and Tax Opinions in
Registered Offerings.
If you intend to file a short form tax opinion, please also
clarify that the disclosure in
this section is the opinion of tax counsel and identify such
counsel.
Where You Can Find More Information, page 408
45. We note your disclosure that "all information contained in this proxy
statement/prospectus
relating to FEAC has been supplied by FEAC," and "all such information
relating to
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
July NameenGene Holdings Inc.
12, 2023
July 12,
Page 9 2023 Page 9
FirstName LastName
enGene has been supplied by enGene" and that "[i]nformation provided
by one another
does not constitute any representation, estimate or projection of the
other." Since these
statements could be read as disclaimers of your responsibility for the
disclosure in your
filing, please revise to remove any implication that FEAC or enGene
disclaim
responsibility for any of the disclosures contained in the
registration statement.
Exhibits
46. With reference to Regulation S-K Item 601, please update your exhibit
index to include all
required exhibits, including material contracts such as the Nature
Technology Corporation
Licensing Agreement described on page 305 and the employment
agreements described
on page 358.
47. We note you intend to file the form of preliminary proxy card as
Exhibit 99.1. Please note
that the form of proxy card should be filed as an appendix rather than
as an exhibit to the
registration statement. Refer to the Note to paragraph (a)(3) of
Exchange Act Rule 14a-4.
General
48. With a view toward disclosure, please tell us whether your sponsor is,
is controlled by, has
any members who are, or has substantial ties with, a non-U.S. person.
Please also tell us
whether anyone or any entity associated with or otherwise involved in
the transaction is, is
controlled by, or has substantial ties with, a non-U.S. person. If so,
please revise your
filing to include risk factor disclosure that addresses how this fact
could impact your
ability to complete your initial business combination. For instance,
discuss the risk to
investors that you may not be able to complete an initial business
combination with a
target company should the transaction be subject to review by a U.S.
government entity,
such as the Committee on Foreign Investment in the United States
(CFIUS), or ultimately
prohibited. Further, disclose that the time necessary for government
review of the
transaction or a decision to prohibit the transaction could prevent
you from completing an
initial business combination and require you to liquidate. Disclose
the consequences of
liquidation to investors, such as the losses of the investment
opportunity in a target
company, any price appreciation in the combined company, and the
warrants, which
would expire worthless.
49. We note that UBS Investment Bank and Kempen & Co were the underwriters
for the
initial public offering of Forbion European Acquisition Corp., that
UBS Securities was
engaged by FEAC as FEAC s co-placement agent for the PIPE financing,
and that SVB
Securities and UBS Securities were engaged by FEAC as FEAC s lead
capital markets
advisor and lead financial and capital markets advisor to FEAC,
respectively. We also
note press reports that certain underwriters are ending their
involvement in SPAC business
combination transactions. Please tell us, with a view to disclosure,
whether you have
received notice from any of those entities, or any of their
affiliates, about ceasing
involvement in your transaction and how that may impact your deal or
any deferred
compensation owed to the underwriters. In addition, please identify
any other financial
Jason Hanson
enGene Holdings Inc.
July 12, 2023
Page 10
advisors who served you or FEAC in connection with the proposed
transaction, and
provide similar disclosure as applicable.
You may contact Sasha Parikh at 202-551-3627 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Tim Buchmiller at 202-551-3635
with any other
questions.
Sincerely,
FirstName LastNameJason Hanson
Division of Corporation
Finance
Comapany NameenGene Holdings Inc.
Office of Life Sciences
July 12, 2023 Page 10
cc: Howard A. Kenny, Esq.
FirstName LastName